Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000377639
Ethics application status
Approved
Date submitted
20/03/2023
Date registered
14/04/2023
Date last updated
21/07/2024
Date data sharing statement initially provided
14/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Co-delivery of tele trial Behavioural Activation in people experiencing depression and financial distress: a feasibility protocol
Scientific title
Changes in depressive symptoms following a tele trial of Behavioural Activation for people experiencing depression and financial distress
Secondary ID [1] 309243 0
Nil none
Universal Trial Number (UTN)
Trial acronym
BAFD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 329399 0
Condition category
Condition code
Mental Health 326343 326343 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A sample of 60 clients in support of a financial support service aged 18 years or above with symptoms of depression as indicated by the PHQ-9 scores of 5-14 (mild to moderate depression) and six Financial Capability Workers (FCW) will be recruited from across six sites in regional, rural, and remote South Australia. Study participants will be randomized to receive Behavioral Activation (BA) plus FWC financial support service care (intervention arm) or FWC financial support service care alone (comparator). The BA component will involve 6 1-1 sessions of 30-minute duration which will be delivered once a week over six weeks. Specific BA techniques that will be applied include the identification of depressed behaviors; analysis of the triggers and consequences of depressed behaviors; monitoring of activities; development of alternative goal-orientated behaviors; scheduling of activities; and the development of alternative behavioral responses to rumination. The FCW will complete a 10-week online training program in BA comprising five modules: (a) the evidence base of BA (b) introduction to BA (c) assessment and mood monitoring (d) functional analysis, and (e) activity scheduling before they can deliver the psychotherapy to their clients. Competency is assessed by asking online participants to complete three video recorded conversations demonstrating the skills to deliver BA, therefore structuring a session, mood monitoring and activity scheduling. If they demonstrate competency, participants are awarded a University of South Australia Professional Certificate in Behavioral Activation. The online training of FCW will occur three months before delivering the six sessions of BA to the participants. Experts in BA will provide supervision to the FCW via a tele health digital platform. This will involve group supervision and, as appropriate, the BA expert will supervise the FCW delivering BA to a client via a secure video link. The tele health digital platform will be used to provide assurance that the FCW are adhering the BA intervention.
Intervention code [1] 325681 0
Behaviour
Comparator / control treatment
Clients in the comparator/control treatment will receive standard care provided by the FCW. This typically involves the FCW providing up to six sessions of 1-1 financial counselling. This involves helping the participant to understand which debts are a priority, developing a budget, negotiating with creditors and understanding your legal rights. Attendance at each session is recorded by the FCW.
Control group
Active

Outcomes
Primary outcome [1] 334198 0
The proportion of people who use the FSW service who report clinically meaningful depressive symptoms as reported by the PHQ 9.
Timepoint [1] 334198 0
Baseline (0) weeks, immediately post intervention (6 weeks)
Secondary outcome [1] 419806 0
Preliminary efficacy of the trial in improving mood. Depressive symptoms will be measured with the Primary Health Questionnaire Nine (PHQ 9).
Timepoint [1] 419806 0
The PHQ 9 will be implemented at three-time points (a) at baseline (0 weeks), (b) at 6 weeks post-completion of intervention, and (c) at 3 months post-completion of the intervention.
Secondary outcome [2] 420731 0
To calculate changes in participant (client) wellbeing. We will administer the SF 36 questionnaire.
Timepoint [2] 420731 0
The SF36 will be implemented at three-time points (a) at baseline (0 weeks), (b) at 6 weeks post-completion of intervention, and (c) at 3 months post-completion of the intervention.
Secondary outcome [3] 420732 0
The proportion of FCW that complete the BA training and the proportion deemed to be competent (calculated by dividing the number of FCW recruited by those that complete the training and those that pass the competency assessments on conclusion of the training).
Timepoint [3] 420732 0
On conclusion of the training.
Secondary outcome [4] 420733 0
The proportion of eligible participants (clients) who agree to participate in the research, calculated by dividing the number of participants (clients) eligible to take part by the number who provide informed consent.
Timepoint [4] 420733 0
Baseline (0) weeks
Secondary outcome [5] 420734 0
Understanding of the FCW and client participants of BA. We will complete semi-structured interviews undertaken with a subset of FCW (minimum of 4) and clients (trial participants (minimum of 8) to explore their experiences of involvement in the feasibility study.
Timepoint [5] 420734 0
3 months post intervention
Secondary outcome [6] 420735 0
The proportion of clients (participants) that complete baseline measures, complete treatment. (calculated by dividing the number of recruited clients (participants) by the number that attend at least six session), and complete follow up measures (calculated by dividing the number of randomized participants by the number that complete the assessment tools at baseline and follow up.
Timepoint [6] 420735 0
Baseline (0) weeks), immediately post intervention (6 weeks) and 3-months post intervention.

Eligibility
Key inclusion criteria
The study will comprise two groups of participants: Financial Capability Workers and FWC clients with depressive symptoms.
(a) Financial Capability Workers
Financial Capability Workers employed by the FWCP who complete training in BA and agree to participate in the study.

(b) FWCP clients with mild-to-moderate depressive symptoms as determined using the PHQ-9 scale
Adults clients of the FWCP who agree to participate in the study, and:
(i) Are aged 18 years or above.
(ii) Are receiving a financial service through FWCP at any of the six participating sites.
(iii) Are experiencing clinically meaningful depressive symptoms and achieve a baseline score of 5-14 (mild to moderate depression) on the PHQ-9 scale as determined via a telehealth platform by the research nurse employed by the Tele-trial team.
(iv) Understand, read, write, and speak English.
(v) Provide informed consent.
Prior or current use of medication or psychotherapy will not be a precluding factor.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) Financial Capability Workers
Workers will not be invited to participate if they advise us that they intend to leave the service in the next 12 months.

b) FWCP Clients
FWCP clients with depressive symptoms who achieve a baseline score of 15+ on the PHQ-9 scale will be excluded from the study for their safety. Similarly, the FWCP clients who express suicidal ideation or present a risk to themselves or others will be excluded for their safety as well as that of the Financial Capability Workers. These potential participants who are excluded will be referred to a general practitioner or mental health professional for support. The FWCP clients already receiving antidepressant medication or any other psychotherapies will be excluded from the study to reduce confounding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following baseline data collection from consenting FWC clients, the trials nurse will insert the unique participant ID into the online randomisation service (sealedenvelope.com) and receive an email confirmation of their group allocation. The allocation sequence is retained by the service and the trials nurse is unaware of group allocation until receiving confirmation for each participant. The tele-trial research nurse will then inform the FWC clients and FCW of treatment allocation. Allocation will be blinded to the data manager/statistician, but it will not be masked to the FCW and research trial nurse who will collect the baseline, post-intervention, and follow-up outcome data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation will be generated by an external computerized randomisation service that uses block randomisation with random permuted block sizes to ensure appropriate allocation concealment and equal sample sizes across groups
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 313431 0
University
Name [1] 313431 0
University of South Australia
Country [1] 313431 0
Australia
Primary sponsor type
Other
Name
SA/NT Regional Clinical Trial Coordinating Centre (SA/NT RCCC)
Address
Office for Research
Department of Health and Wellbeing
Clinical Collaborative/System Leadership and Design
Level 5
Citi Centre Building
11 Hindmarsh Square
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 315201 0
None
Name [1] 315201 0
Address [1] 315201 0
Country [1] 315201 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312642 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 312642 0
Ethics committee country [1] 312642 0
Australia
Date submitted for ethics approval [1] 312642 0
04/04/2023
Approval date [1] 312642 0
04/08/2023
Ethics approval number [1] 312642 0
205435

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125394 0
Ms Sandra Walsh
Address 125394 0
Department of Rural Health, University of South Australia, 111 Nicolson Avenue, Whyalla SA 5608
Country 125394 0
Australia
Phone 125394 0
+61 439328641
Fax 125394 0
Email 125394 0
sandra.walsh@unisa.edu.au
Contact person for public queries
Name 125395 0
Sandra Walsh
Address 125395 0
Department of Rural Health, University of South Australia, 111 Nicolson Avenue, Whyalla SA 5608
Country 125395 0
Australia
Phone 125395 0
+61 439328641
Fax 125395 0
Email 125395 0
sandra.walsh@unisa.edu.au
Contact person for scientific queries
Name 125396 0
Sandra Walsh
Address 125396 0
Department of Rural Health, University of South Australia, Whyalla Campus, Whyalla Norrie SA 5608
Country 125396 0
Australia
Phone 125396 0
+61 439328641
Fax 125396 0
Email 125396 0
sandra.walsh@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data reporting the outcomes of the study after results have been published.
When will data be available (start and end dates)?
Immediately following publication with no end date.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator Martin Jones who can be contacted at martin.jones@unisa.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18628Study protocol    We will publish our protocol
18629Statistical analysis plan    We will publish our protocol
18630Ethical approval    We will publish our protocol.


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.